Question 1

What is Quality Smart Solutions?

Accepted Answer

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Question 2

Where does Quality Smart Solutions operate?

Accepted Answer

We serve global clients from our North American headquarters by offering trusted compliance services.

Question 3

Why should you trust Quality Smart Solutions?

Accepted Answer

We take a personal approach to every client’s needs and goals. Our mission is to see your business thrive through compliance and risk mitigation. With a team of former FDA and Health Canada regulatory agency officials, regulatory experts, quality assurance specialists and  industry professionals we  provide insights and strategies to navigate the complex journey of regulations to help you make clear, decisive decisions to grow your business.

Question 4

How can Quality Smart Solutions help me with my Health Canada compliance?

Accepted Answer

Quality Smart Solutions can help you with get and remain FDA and Health Canada compliant with the following services:
NHP- NPN License, Label Compliance, Site License, Importer of Record
Food- Label Compliance, TMAL Registration, SFCR Food License, PCP and HACCP Food Safety
Medical Devices- IDV Registration, MDEL Registration, MDL Label Compliance, Medical Device Registration
OTC Drug- DIN Registration, Disinfectant Licensing, Label Compliance, DEL Registration
Cosmetics- Cosmetic Notification, Label Compliance Review, Hot List Check
Veterinary Health Products- VHP Notification Number, PSL Submission, Label Compliance, Canadian Representative

Question 5

How can Quality Smart Solutions help me with my FDA compliance?

Accepted Answer

Dietary Supplement- Label Compliance, 30-Day Pre Market Notification, New Dietary Ingredient Notification filing and Facility Registration
Food- Label Compliance And Nutrition Facts Panel Creation, Facility Registration and US Agent, FOOD Safety and FSVP Agent, GRAS Self Affirmation Or Notice Filing
Medical Devices- 510(k) Filing, Facility Registration And US Agent, IN-Vitro Diagnostic Test Registration, Label Review
OTC Drug- NDC and Drug Notification, Facility Registration And US Agent, Abbreviated New Drug Application (ANDA), Label Compliance
Disinfectant- EPA Registration, Label Review, Facility Registration Claims Substantiation
Cosmetics- Claims Assessment, Label Compliance

Question 6

Why compliance with Canada's FDA is critical for the success of your business?

Accepted Answer

Navigating the world of business is no easy feat, especially when it comes to regulatory compliance. As an entrepreneur, it's crucial to ensure that all aspects of your business are in accordance with the laws and regulations of the country you operate in. In Canada, one of the most important regulatory bodies is the FDA (Food and Drug Administration). Compliance with the FDA is critical for the success of your business, particularly if you're involved in the food or healthcare industry. Failure to comply with FDA regulations can result in hefty fines, recalls, or even legal action against your business. In this article, we'll take a closer look at why compliance with Canada's FDA is so crucial for your business and what steps you can take to ensure that you're meeting all the necessary requirements. So, whether you're a small business owner or a large corporation, this is a topic you can't afford to ignore.

Question 7

Why Compliance with Canada's FDA is Important?

Accepted Answer

Compliance with Canada's FDA is essential for businesses that operate in the food and healthcare industries. The FDA is responsible for regulating products that affect the health and safety of Canadians, including food, drugs, medical devices, and cosmetics. Compliance with FDA regulations ensures that these products are safe for consumption and use by Canadians. 
Compliance with FDA regulations also helps to build trust with your customers. When customers see that you're taking the necessary steps to ensure the safety and quality of your products, they're more likely to trust your brand. This trust can translate into increased sales and customer loyalty over time. 
Another reason why compliance with Canada's FDA is important is that it helps to protect your business from legal action. If your business fails to comply with FDA regulations, you could face hefty fines, recalls, or even legal action. This can be devastating to your business, both financially and reputation-wise.

Question 8

What are the consequences of Non-Compliance with Canada's FDA?

Accepted Answer

The consequences of non-compliance with Canada's FDA can be severe. If your business fails to comply with FDA regulations, you could face fines, recalls, or legal action. These consequences can be particularly devastating for small businesses that may not have the financial resources to weather the storm. 
Fines for non-compliance can range from a few thousand dollars to hundreds of thousands of dollars, depending on the severity of the violation. Recalls can also be costly, as they require businesses to remove products from the market and potentially destroy them. Legal action can be even more devastating, as it can result in the closure of your business and even personal liability for business owners. 
In addition to these financial consequences, non-compliance with Canada's FDA can also damage your business's reputation. If customers discover that your products are unsafe or don't meet FDA regulations, they're likely to lose trust in your brand. This loss of trust can translate into decreased sales and difficulty attracting new customers.

Question 9

What are the legal requirements for compliance with Canada's FDA?

Accepted Answer

In Canada, compliance with FDA regulations is mandatory for businesses that operate in the food and healthcare industries. These regulations are designed to ensure the safety and quality of products that affect the health and safety of Canadians. 
To comply with FDA regulations, businesses must follow specific guidelines and procedures. These guidelines cover everything from product labeling to manufacturing processes to advertising and marketing practices. 
Businesses are also required to obtain certain licenses and permits to operate in the food and healthcare industries. For example, businesses that sell food products must obtain a food license from the Canadian Food Inspection Agency (CFIA). Similarly, businesses that manufacture medical devices must obtain a Medical Device Establishment License (MDEL) from Health Canada.

Question 10

What are the steps for ensuring compliance with Canada's FDA?

Accepted Answer

Ensuring compliance with Canada's FDA can be a complex process, but there are steps businesses can take to ensure that they're meeting all the necessary requirements. 
The first step is to understand the FDA regulations that apply to your business. This may require consulting with legal experts or regulatory consultants who can help you navigate the regulatory landscape. 
Once you understand the regulations that apply to your business, you can begin implementing the necessary procedures and processes to ensure compliance. This may involve investing in new equipment, training employees, or establishing new policies and procedures. 
Regular audits and inspections can also help businesses ensure compliance with FDA regulations. These audits and inspections can identify areas where businesses need to improve their processes or procedures to meet FDA standards.

Question 11

What are the benefits of compliance with Canada's FDA?

Accepted Answer

Compliance with Canada's FDA offers numerous benefits for businesses that operate in the food and healthcare industries. 
One of the most significant benefits is improved customer trust and loyalty. When customers see that your business is taking the necessary steps to ensure the safety and quality of your products, they're more likely to trust your brand and become loyal customers. 
Compliance with FDA regulations can also help businesses avoid costly fines and legal action. By ensuring compliance with FDA regulations, businesses can protect themselves from the financial and reputational damage that can result from non-compliance. 
Finally, compliance with FDA regulations can help businesses stay ahead of their competitors. Businesses that comply with FDA regulations are more likely to be perceived as industry leaders and innovators, which can give them a competitive advantage in the marketplace.

Question 12

What are the challenges in maintaining compliance with Canada's FDA?

Accepted Answer

Maintaining compliance with Canada's FDA can be challenging, particularly for small businesses that may not have the resources to dedicate to regulatory compliance. 
One of the biggest challenges is keeping up with changing regulations and guidelines. FDA regulations are constantly evolving, and businesses must stay up-to-date with these changes to ensure compliance. 
Another challenge is the cost of compliance. Implementing new procedures and processes to meet FDA standards can be costly, particularly for small businesses that may not have the financial resources to invest in new equipment or training. 
Finally, maintaining compliance with FDA regulations requires ongoing effort and dedication. Businesses must be committed to regularly auditing and inspecting their processes and procedures to ensure that they're meeting FDA standards.

NHP NPN License Label Compliance Site License Importer of Record See All	Food Label Compliance TMAL Registration SFCR Food License PCP and HACCP Food Safety See All	Medical Devices Medical Device Registration IVD Registration MDEL Registration MDL Label Compliance See All
OTC Drug DIN Registration Disinfectant Licensing Label Compliance DEL Registration See All	Cosmetics Cosmetic Notification Label Compliance Review Hot List Check See All	Veterinary Health Products VHP Notification Number PSL Submission Label Compliance Canadian Representative See All

Proven Expertise

Proof in
Numbers

Why Quality Smart Solutions?

Serving You First

Decades of Experience

Import Solutions

We Help You Grow Globally

Here to Serve You across North America

Hear from some of our Clients

Proudly partnered with over 3500+ clients

Our Divisions Serve Your Growth

Articles

FDA 510(k) pre-submissions vs PMA: What’s the difference?

How to Strengthen Operations with GMP Training

How Audits Help You Stay Compliant with Health Canada

How to Comply with the FDA’s NDI Notification Process

Subscribe to global regulatory updates

Subscribe to global regulatory updates

Proven Expertise

Proof in Numbers

Why Quality Smart Solutions?

Serving You First

Decades of Experience

Import Solutions

We Help You Grow Globally

Here to Serve You across North America

Hear from some of our Clients

Proudly partnered with over 3500+ clients

Our Divisions Serve Your Growth

Articles

FDA 510(k) pre-submissions vs PMA: What’s the difference?

How to Strengthen Operations with GMP Training

How Audits Help You Stay Compliant with Health Canada

How to Comply with the FDA’s NDI Notification Process

Subscribe to global regulatory updates

Subscribe to global regulatory updates

Proof in
Numbers